Early PE for Autoimmune Encephalitis

Not Applicable

Completed

• Conditions: Autoimmune Encephalitis
• Interventions: Procedure: Plasma exchange (PE); Drug: intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP)

• Registration Number: NCT03542279
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

Plasma exchange (PE) is one of the first-line therapies for autoimmune encephalitis (AE) patients, but the optimal timing of PE remains unclear. The study is tocompare the efficacy between early PE and late PE in patients with severe antibody-associated autoimmune encephalitis (AE).

Detailed Description

Patients with AE will be randomly divided into the early PE group and late PE group according to the random table. All patients will receive tumour screening, symptomatic supportive treatment, and immunotherapy. The immunotherapy includes intravenous methylprednisolone (IVMP), intravenous gamma immunoglobulin (IVIG; 0.4 g/kg/d for each course for 5 d), PE and immunosuppressants. Patients in the early PE group received PE and IVMP treatment without delay, followed by IVIG immediately after PE treatment. Patients in the late PE group were given IVIG (0.4g/kg/d for 5 days) and IVMP immediately, followed by PE at least 2 weeks after IVIG treatment. The patients received long-term immunotherapy involving a combination of oral corticosteroids and immunosuppressants (such as mycophenolate mofetil at a dose of 1-2g/d) for 6-12 months if no contraindications. The primary outcome is the proportion of patients achieving functional improvement \[a decrease of at least 1 point in modified Rankin Scale (mRS) score\] at 3 months after immunotherapy.

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-31
• Study Start: 2020-11-25
• Primary Completion: 2022-12-12
• Study Completion: 2024-09-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Late PE group	intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP)	IVIG (0.4g/kg/d for 5 days) and IVMP immediately, followed by PE at least 2 weeks after IVIG treatment.
Early PE group	Plasma exchange (PE)	PE (5 times in each course) combined with intravenous methylprednisolone (IVMP) and IVIG after PE.
Early PE group	intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP)	PE (5 times in each course) combined with intravenous methylprednisolone (IVMP) and IVIG after PE.
Late PE group	Plasma exchange (PE)	IVIG (0.4g/kg/d for 5 days) and IVMP immediately, followed by PE at least 2 weeks after IVIG treatment.

Primary Outcome Measures

Name	Time	Method
proportion of subjects achieving functional improvement	3 months following Immunotherapy	Functional improvement is defined as a decrease of at least 1 point in mRS score, modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.

Secondary Outcome Measures

Name	Time	Method
CASE score	24 months following Immunotherapy	Clinical Assessment Scale in Autoimmune Encephalitis
Length of ICU stay	before discharge	Length of ICU stay (days)
modified Rankin Scale	24 months following Immunotherapy	modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
proportion of favorable outcome	24 months following Immunotherapy	A mRS score of 0-2 was considered a favorable outcome, whereas a mRS score of 3-6 was graded as an unfavorable one.; modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.

Trial Locations

Locations (1)

Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China